Telemedicine in Heart Failure: Studies of Treatment, Prognosis and Patient Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Heart failure is a common and serious disease responsible for significant healthcare costs and the need of hospitalizastions. The course of the disease is characterized by periods of progressive deterioration with repeated hospital admissions, especially in the final stages of life. Telemedical self-monitoring is a promising alternative for remote monitoring that can provide individualized treatment, smooth titration of medications and reduce hospital stays. However, the evidence for its benefits is limited, which requires further research.
Our hypotheses are that self-monitoring in heart failure can:
- Reduce avoidable inpatient care and mortality.
- Optimize the escalation of medications to optimal medical therapy.
- Increase self-care and security.
- Improve the prediction of deterioration in heart failure. Work Plan: We will compare six months of telemedical monitoring with standard care, and integrate telemedical data with electronic health records (EHR) for analysis and development of prognostic models for clinical outcomes (data collection is ongoing). Consecutive heart failure patients (target 300) will receive digital equipment for reporting vital parameters, experiences, and symptoms over six months. Medication adjustments are made remotely, and physical visits as needed. Data on mortality, healthcare needs, and health economics will be collected over two years after the monitoring period. We plan to retrieve a matched control population from the Swedish heart failure registry (SwedeHF). Telemonitoring data and EHR will be analyzed with traditional regression models and machine learning for identifying predictive factors for i) death, ii) readmission for heart failure or other cardiovascular disease.
Significance: The study can contribute to more cost-effective, patient-centered, and medically purposeful care of heart failure.
详细描述
Heart failure (HF) affects 2% of the population, rising to 10% in individuals over 80 years, causing considerable healthcare costs and suffering. In newly diagnosed HF titration of medication to optimal medical therapy (OMT) usually requires multiple physical visits in specialized clinics. Recent advances have enabled telemonitoring, wireless transmission of sensor-generated health data as an alternative which need scientific evaluation.
HF is characterized by periods of stability followed by episodic deterioration, with reduced quality of life (QoL) and hospitalizations. Decline in vital signs appear long before symptoms occur, successively leading to a point when hospitalization cannot be avoided. Telemonitoring allows for consistent monitoring of vital parameters, which potentially may guide treatment and prevent hospitalizations. It also promotes patient empowerment and personalized treatment. The European Society of Cardiology's (ESC) guidelines for HF, 2021 calls for further research on real world telemedicine data to optimize patient selection, equipment, and protocols. The Swedish national HF register, SwedeHF, contains detailed data on the majority of acute HF patients, providing an excellent opportunity to generate a well characterized matched real world population, including yearly up-dates of clinical information. In addition, electronic health records (EHRs) are an increasingly important source for studies of routinely collected healthcare data, offering granular real world data for research and prognostic modeling.
Work plan: Can RPM/telemonitoring for HF provide effective, safe and cost-efficient care with high patient satisfaction? We will compare six months of telemonitoring intervention with standard care to study clinical outcomes, patient experience and health economics (data collection in progress).
Participants: Consecutive HF patients (≥18 years) at specialized HF clinics are being recruited for intervention. Inclusion criteria are new or worsening HF in patients requiring monitoring due to a) titration of medication to OMT or b) decompensation requiring regular physical monitoring.
Intervention: Patients receive equipment for report of vital signs and patient reported experience measures (PREMS), automatically transmitted via smartphone/bluetooth for six months (possible extension to 12 months in case of instability). A digital smartphone application is used for registration and transmission of data, including modes for asynchronous (chat) communication with the healthcare provider. Planned titration to OMT or diuretic adjustments may be done remotely depending on clinical assessment. The digital sensors include an electronic scale, pulse and blood pressure monitor for daily measurements by the patient. The healthcare provider is notified of abnormal values, with services provided during office hours. Physical visits will be planned on a need-to basis. A care plan for target OMT or adjustments of diuretic treatment is established.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Mortality
时间窗: up to 2 years after start of study
All mortality and cardiovascular mortality
Hospitalizations
时间窗: up to 2 years after start of study
Re-hospitalizations, days hospitalized
Number of contacts in out-patient clinical care
时间窗: up to 2 years after start of study
Primary and specialized care
EQ5D
时间窗: up to 2 years after start of study
General health report containing 5 dimension of general health (graded 1-3) and a general comprehensive self-estimate of general health (0-100) where the highest values correspond to the highest level of general health.
次要结局
- Sense of security in care(up to 2 years after start of study)
- General self-efficacy scale(up to 2 years after start of study)
研究者
Helen Sjoland
Associate professor
Sahlgrenska University Hospital, Sweden
